Nutrition Care in Patients Living With Chronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLinkoeping University
About this trial
The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain.
Part I: Included 20 patients with complex chronic pain to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes.
Part II: Included 192 patients with complex chronic pain. Half of the participants receive IPRP and nutrition care (described above) and the other half receive standard IPRP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self reported Body Mass Index (BMI)>=25;
Written consent to participate and attend to the pain rehabilitation program due to disabling chronic pain (on sick leave or experiencing major interference in daily life due to chronic pain)
Agreement not to participate in other parallel treatments for weight reduction
Not currently using medications of weight reduction
Disqualifiers
Health conditions such as pregnancy, active metabolic disease, rheumatoid arthritis, and serious psychiatric disease (investigator's judgement, eg, psychosis or suicidal ideation);
Coagulation disorders with predisposition to bleeding, medication with anticoagulants (low- dose aspirin is permitted);
hypersensitivity to anaesthetic
Difficulties in understanding the Swedish language.
Trial design
Design model
Parallel
Treatments tested in this trial
Nutrition care
Other interventionNutrition care is designed to include nutrition assessment (e.g., malnutrition screening, monitoring weight changes, etc.), optimization of individual dietary patterns, and evaluation. Through the Diet4painrelief platform, a dietician will follow up the progress of each participant in different timepoints and also plan meetings with other professionals in IPRP. A dietitian together with a physician in rehabilitation are responsible for the administration of the procedure.
Dialogue and education (part of Interdisciplinary Pain Rehabilitation Program)
BehavioralDialogue and education consists of patient education, training in wellness and healthy living habits, meetings with families, video feedback, and couples therapy and self-training (e.g., home lessons, activity diary, physical self-training, reflection time, and self-analysis. . In addition, lectures in basic pain science and pain management are offered for both patients as well as for relatives, friends, and colleagues.
activity training (part of Interdisciplinary Pain Rehabilitation Program)
BehavioralActivity training includes graded activity training, and exposure training, which are delivered by an interdisciplinary team (i.e., a physiotherapist, an occupational therapist, and a psychologist).
meetings (part of Interdisciplinary Pain Rehabilitation Program)
BehavioralThe meetings consist of conferences with patients, rehabilitation team, vocational guidance, rehabilitation coordinator, goal-setting meetings, and meetings to check goal achievement.
Cognitive behavioral therapy (part of Interdisciplinary Pain Rehabilitation Program)
BehavioralAcceptance and Commitment Therapy (ACT, e.g., goal compass, training in ACT principles, and mindfulness) is mainly delivered by psychologist in a group-treatment (e.g., training in coping strategies). The cognitive behavioral principles are also used in physiotherapy, ergonomics, and education in pain management.
Relaxation techniques (part of Interdisciplinary Pain Rehabilitation Program)
BehavioralThis group-treatment is mainly format by a physiotherapist and psychologist in an interdisciplinary team.
Physical exercise (part of Interdisciplinary Pain Rehabilitation Program)
BehavioralThis group-treatment is mainly format by a physiotherapist in an interdisciplinary team.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Standard IPRPActive comparator 6 interventions
Group B: IPRP and nutrition careExperimental treatment 7 interventions
Trial outcomes
Primary outcomes
1
Pain intensity (numeric rating scale)
A numeric rating scale, 0=no pain, 10=worst pain experienced
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up2
Pain interference (one aspect in Multidimensional Pain inventory)
Multidimensional Pain inventory Swedish version is based on 11 items, each scored 0-6. To measure pain-related interference in everyday life, 0 = no interference, 6 = extreme interference
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) ) and later at 12-month follow-up3
Dietary habits (a lifestyle questionnaire)
A lifestyle questionnaire measures self-reported regular mealtime, frequency of vegetables and fruits intake, frequency of fast-food and confectionary consumption.
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up4
Perceived Usability (System Usability Scale)
System Usability Scale (0-100) is composed of 10 statements that are scored on a 5-point scale of strength of agreement.
Time frame
Participants will be asked about their perceived benefit twice, after the rehabilitation (12 weeks) and later at 12-month follow-up.Secondary outcomes
1
Difficulty sleeping (Insomnia Severity Index)
Insomnia Severity Index (ISI, 0-28) consists of 7 items and each is scored 0-4. The score is divided into 4 categories: no clinically significant insomnia (ISI 0-7); sub-threshold insomnia (ISI 8-14); moderate clinical insomnia (ISI 15-21); and severe clinical insomnia (ISI 22-28).
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.2
Emotional distress (The Hospital Anxiety and Depression Scale, HAD)
Depression and Anxiety using Hospital Anxiety and Depression Scale (0-42). One subscale (depression or anxiety) has seven items with a scoring range of 0 to 21; the lower score indicates a lower possibility of anxiety or depression.
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.3
Impact of chronic pain (Multidimensional Pain inventory)
Multidimensional Pain inventory Swedish version- Life control (0-6) is based on 4 items, each scored 0-6. A higher score indicates a better control.
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.4
Health- related quality of life 1 (EQ-5D)
EQ- 5D, Consists of two parts. The first part is an index obtained from five dimension items scored 0-5. The second part is self- estimation of today's health according to a 100- point thermometer- like scale (EQ5D- VAS) with defined end points (high values indicate better health and low values indicate worse health).
Time frame
Participants will complete the questionnaires before, immediately after the rehabilitation (12 weeks) and later at 12-month follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Linkoeping University
Lead sponsor
Ostergotland County Council, Sweden
Collaborator
Source ClinicalTrials.gov